Roche suspends enrollment in anemia drug trial

By Sam Cage

ZURICH (Reuters) - Swiss drugmaker Roche Holding AG said on Friday it suspended enrollment in a clinical trial of its experimental anemia drug because of safety concerns.

The news casts a further cloud over a class of drugs that include Amgen Inc.'s Aranesp and Epogen, and Johnson & Johnson's Procrit.

Roche said it is temporarily suspending recruitment of anemic lung cancer patients into a mid-stage trial of CERA (Continuous Erythropoiesis Receptor Activator) because of an "imbalance" of deaths across the four arms of the study.

The company said the deaths were unrelated to the study drugs and there appeared to be no association of the events to excessive levels of hemoglobin, the red component of blood that carries oxygen to the rest of the body.

Roche said the deaths were driven in part by the progression of the cancer, a finding that can only fuel a growing concern that drugs comprised of the natural protein erythropoietin may feed cancerous tumors and help them grow.

Analysts said the news represents a double-edged sword for Amgen, the world's biggest biotechnology company, which has been seeking to block CERA from entering the U.S. market and competing with its largest products. Aranesp alone generates annual sales of roughly $4 billion.

Amgen executives were not immediately available for comment.

The news will likely add to growing concern among regulators about the safety of all erythropoietin drugs, especially when given in higher doses, and it may make it less likely that CERA will be approved by the U.S. Food and Drug Administration -- a potential boon to Amgen.

"Approving CERA has to have fallen a few notches on the FDA's to-do list," said Christopher Raymond, an analyst at R.W. Baird & Co. "This is unequivocally good news for Amgen."

Roche did not reveal the number of deaths in each of the four arms of the trial, which compared patients taking different doses of CERA with patients taking Aranesp.

Raymond and others infer there were more deaths in the CERA arms of the trial than in the Aranesp arm.

On Jan. 25 Amgen disclosed a higher risk of death among cancer patients not undergoing chemotherapy who were treated with Aranesp, compared with those receiving placebos.

The study involved patients with anemia and active cancer who were not receiving chemotherapy or radiation - a group of seriously ill patients for whom Aranesp is not formally approved.

Amgen said results of the trial suggest that the risk of taking Aranesp is not warranted for such patients taking Aranesp on an "off-label" basis - which analysts said is responsible for more than 10 percent of the drug's sales.

Amgen's setback last month comes on the heels of a study that cast a negative light on Procrit, J&J's form of erythropoietin, and possible over-use of such medicines.

The U.S. Food and Drug Administration in November said it would review the study, which showed that kidney disease patients treated more aggressively with Procrit had a higher risk of cardiac complications and death.

(Additional reporting by Toni Clarke in Boston and Ransdell Pierson in New York)